Prescription drug · ANDA
Cephalexin NDC 68071-5038
Cephalexin 250 mg/5mL · For suspension · Oral · NuCare Pharmaceuticals,Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-5038-0 | 68071503800 | 100 mL in 1 BOTTLE (68071-5038-0)Marketed from Aug 21, 2019 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Cephalexin
- Generic name (nonproprietary)
- cephalexin
- Active ingredients
- Cephalexin — 250 mg/5mL
- Dosage form
- For suspension
- Route
- Oral
- Labeler
- NuCare Pharmaceuticals,Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210221
- Marketing start
- Listing expires
- Other FDA classes
- Cephalosporins (Chemical structure)
- Identifiers
- Product ID 68071-5038_1b410dbc-8ddc-344b-e063-6294a90a840bSPL ID 1b410dbc-8ddc-344b-e063-6294a90a840bSPL set ID 90a76d24-e5a9-9000-e053-2a95a90ae8afRxCUI 309113UNII OBN7UDS42YUPC 0368071503807
- Pharmacologic class
- Cephalosporin Antibacterial
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N468071503800followed by a unit qualifier and the quantityPackage 68071-5038-00. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Cephalexin is a cephalosporin antibacterial drug indicated for the treatment of the following infections caused by susceptible isolates of designated bacteria: • Respiratory tract infection (1.1) • Otitis media (1.2) • Skin and skin structure infections (1.3) • Bone infections (1.4) • Genitourinary tract infections (1.5) To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin and other antibacterial drugs, cephalexin should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. (1.6) 1.1 Respiratory Tract Infections Cephalexin is indicated for the treatment of respiratory tract infections caused by susceptibl…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 210221
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Cephalexin | Cephalexin 250 mg/5mL | For suspensionOral | NuCare Pharmaceuticals,Inc. | 68071-2889 |
| Cephalexin | Cephalexin 250 mg/5mL | For suspensionOral | A-S Medication Solutions | 50090-5196 |
| Cephalexin | Cephalexin 250 mg/5mL | For suspensionOral | Bryant Ranch Prepack | 71335-2877 |
| Cephalexin | Cephalexin 250 mg/5mL | For suspensionOral | Bryant Ranch Prepack | 63629-8857 |
| Cephalexin | Cephalexin 250 mg/5mL | For suspensionOral | Bryant Ranch Prepack | 63629-8858 |
| Cephalexin | Cephalexin 125 mg/5mL | For suspensionOral | NuCare Pharmaceuticals,Inc. | 68071-2246 |
| Cephalexin | Cephalexin 250 mg/5mL | For suspensionOral | REMEDYREPACK INC. | 70518-4511 |
| Cephalexin | Cephalexin 250 mg/5mL | For suspensionOral | Bryant Ranch Prepack | 72162-1851 |
| Cephalexin | Cephalexin 125 mg/5mL | For suspensionOral | Bryant Ranch Prepack | 72162-1850 |
| Cephalexin | Cephalexin 250 mg/5mL | For suspensionOral | A-S Medication Solutions | 50090-4795 |
| Cephalexin | Cephalexin 250 mg/5mL | For suspensionOral | Preferred Pharmaceuticals, Inc. | 68788-7529 |
| Cephalexin | Cephalexin 125 mg/5mL | For suspensionOral | Ascend Laboratories, LLC | 67877-544 |
| Cephalexin | Cephalexin 250 mg/5mL | For suspensionOral | Ascend Laboratories, LLC | 67877-545 |
| Cephalexin | Cephalexin 125 mg/5mL | For suspensionOral | Bryant Ranch Prepack | 63629-9204 |
| Cephalexin | Cephalexin 125 mg/5mL | For suspensionOral | Bryant Ranch Prepack | 63629-9205 |
| Cephalexin | Cephalexin 250 mg/5mL | For suspensionOral | Bryant Ranch Prepack | 63629-9206 |
| Cephalexin | Cephalexin 250 mg/5mL | For suspensionOral | Bryant Ranch Prepack | 63629-9207 |
| Cephalexin | Cephalexin 250 mg/5mL | For suspensionOral | Bryant Ranch Prepack | 71335-2734 |
| Cephalexin | Cephalexin 250 mg/5mL | For suspensionOral | Bryant Ranch Prepack | 71335-2986 |
| Cephalexin | Cephalexin 125 mg/5mL | For suspensionOral | Preferred Pharmaceuticlas Inc. | 68788-7796 |